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Vaccine Holds Promise for Lyme Disease.

Lyme disease is the most common vector-borne illness in the U.S.: more than 15,000 cases are diagnosed yearly. Two large trials demonstrate the safety and efficacy of the first Lyme disease vaccine to be widely tested in humans.

Vaccine preparations composed of a recombinant borrelial outer-surface lipoprotein were administered with adjuvant in the first study (supported by SmithKline Beecham), and without adjuvant in the second (supported by Pasteur Merieux Connaught). Over 21,000 adults from Lyme-endemic areas of the U.S. (primarily New England) received two doses of either vaccine or placebo spaced a month apart during the early spring months before Lyme season, followed by a booster dose one year later.

The vaccine preparations with or without adjuvant reduced confirmed cases of Lyme disease during the first year (by 49 percent and 68 percent, respectively), and even more so during the second (by 76 percent and 92 percent, respectively.) The first study reported significantly lower rates of asymptomatic seroconversion and fewer cases of "possible" Lyme in vaccine recipients than in the placebo group. Side effects (primarily local reactions) were reported by 10 to 25 percent of vaccine recipients.

Comment: FDA approval is underway for this vaccine, and it should be available for general use in endemic areas shortly. The specific indications for its use are still unclear; an editorial reminds us that its safety and efficacy in children and adolescents, who contract almost 25 percent of all cases of Lyme disease, are unknown.

— A Zuger

Published in Journal Watch General Medicine August 4, 1998

Citation(s):

Steere AC et al. Vaccination against Lyme disease with recombinant Borrelia burgdorferi outer-surface lipoprotein A with adjuvant. N Engl J Med 1998 Jul 23 339 209-215.

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Sigal LH et al. A vaccine consisting of recombinant Borrelia burgdorferi outer-surface protein A to prevent Lyme disease. N Engl J Med 1998 Jul 23 339 216-222.

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Steigbigel RT and Benach JL. Immunization against Lyme disease -- An important first step. N Engl J Med 1998 Jul 23 339 263-264.

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